BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM 1000 SPDS

    MDR report key: 488790 · Received October 8, 2003

    Report

    Report Number
    1423500-2003-01030
    Event Type
    Injury
    Date Received
    October 8, 2003
    Date of Event
    September 17, 2003
    Report Date
    September 18, 2003
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FKP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    BAXTER GLOBAL COMPLAINT COORDINATOR REPORTED THAT A PATIENT HAD A FEELING OF MALAISE, DECREASED ARTERIAL PRESSURE, BREATHING DIFFICULTIES, SWELLING OF LIPS AND EYELIDS AND WAS SWEATING DURING A TREATMENT ON A SYSTEM 1000 MACHINE. THE SYMPTOMS OCCURRED AT THE BEGINNING OF TREATMENT AS SOON AS THE PATIENT BLOOD REACHED THE PATIENT VENOUS ACCESS. THE PATIENT ARTERIAL PRESSURE WAS 200/102 AND WAS MEASURED WAS MEASURED EVERY 5 MINUTES. THE LAST ARTERIAL PRESSURE MEASURED WAS 185/95. THE NURSE IMMEDIATELY STOPPED THE TREATMENT AND DISCONNECTED THE PATIENT. THE BLOOD THAT EXISTED IN THE EXTRA-CORPOREAL CIRCUIT WAS NOT RETURNED TO THE PATIENT. THE MALAISE SYMPTOMS DISSIPATED AFTER THIRTY MINUTES. THE PATIENT WAS TRANSFERRED TO THE HOSPITAL AND DIALYZED WITHOUT ISSUE THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 1000 SPDS HEMODIALYSIS MACHINE FKP BAXTER HEALTHCARE CORP. SYSTEM 1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization BAXTER FISTULA NEEDLE MANUFACTERED BY NIPRO, 2003,| HOSMED BLOODLINE, 2003.| TRICEA 210G DIALYZER, 2003,